The Q1 Scientific Stability Studies Conference is set to be an unmissable event for analytical and quality professionals working for pharmaceutical and medical device companies. Scheduled for October 17, 2024, at the Killashee Hotel in Kildare, this conference promises a wealth of knowledge and networking opportunities.
Benefits of attending our Stability Studies conference
Participating in the Q1 Scientific Stability Studies Conference offers numerous benefits:
- Networking opportunities: Connect with peers, experts, and thought leaders to build valuable professional relationships.
- Career advancement: Enhance your expertise and stay updated on industry best practice, which can open doors to new opportunities and make you a valuable asset to your company.
- Practical insights: Learn actionable insights that you can directly apply to your work. Whether it’s improving your stability study processes or navigating regulatory requirements, the conference will equip you with practical tools and strategies.
- Expert knowledge: Gain insights from industry leaders like Dr. Nuala Calnan, Stan O’Neill, Catherine McHugh, Dr. Mark Powell, Kate Coleman and Stephen Delaney. Their expertise in quality risk management, regulatory compliance, and stability studies will provide you with best practice knowledge and practical strategies.
What can I expect to learn at the Stability Studies 2024 conference?
This year, we are excited to feature a lineup of incredible guest speakers who bring a wealth of knowledge and experience. Here’s a closer look at some of the key speakers, their backgrounds, and the topics they will be presenting.
Dr. Nuala Calnan
Dr. Nuala Calnan is a 25-year veteran of the pharmaceutical industry. Her work as a consultant, academic, author, and commentator is directed toward the development of practical, patient-focused excellence. She has conducted research for the FDA (USA) and HPRA (Ireland) on risk surveillance, patient safety, and product quality in drug manufacturing and distribution.
Presentation Topic: “Stability Testing from Bench to Bedside: Understanding the Why”
Overview: Nuala will delve into the critical role of stability testing in ensuring patient safety. She will discuss key regulatory frameworks, the importance of missed stability tests, and strategies for fostering a patient-focused culture of excellence in QC laboratory operations.
Dr. Mark Powell
Dr. Mark Powell is a Fellow of the Royal Society of Chemistry with over 30 years of experience as a senior analytical chemist. He has held significant roles in various companies, focusing on analytical development and equipment qualification.
Presentation Topic: “Addressing Out-of-Trend and Variable Stability Data”
Overview: Dr. Powell will highlight common causes of variable or anomalous stability data and suggest ways to mitigate these issues. His presentation will provide practical insights into improving the quality of stability data.
Kate Coleman
Kate Coleman is the VP of Regulatory Affairs, Quality, and Compliance at Arriello. With over 20 years of experience in the pharmaceutical industry, she is a Qualified Person, Principal Consultant, Lead Auditor, and an SME in several areas including Quality Control and Stability.
Presentation Overview: Kate will share her extensive knowledge and experience in regulatory affairs, quality, and compliance, providing valuable insights into stability programs.
Stephen Delaney
Stephen Delaney is the Managing Director at Q1 Scientific, a Cambrex company. He has extensive experience in stability storage management and quality assurance.
Presentation Topic: “From Storage to Success: Navigating Stability Challenges”
Overview: Stephen will discuss the strategic decision-making, collaboration, and flexible approaches required to navigate stability challenges. He will cover topics such as insourcing vs. outsourcing, real-life case studies, and best practices for success.
Stan O’Neill
Stan O’Neill is the Managing Director of The Compliance Group. He has a background in pharmacy and extensive experience in regulatory affairs, marketing, and quality assurance. He has also worked as a Senior Inspector for the HPRA.
Presentation Topic: “GMP Considerations for Stability Testing”
Overview: Stan will explore the obligations for ongoing stability testing during the post-approval stage of the product life cycle. He will focus on adopting a lean approach and addressing issues when they arise.
Catherine McHugh
Catherine McHugh is the Owner and Director of Imbolc Pharma Consulting. She has over eight years of experience as a Pharmaceutical Assessor with the HPRA and has worked as a Regulatory/CMC consultant for global consulting organizations.
Presentation Topic: “Navigating Stability Data Challenges: Insights from Regulatory Experience”
Overview: Catherine will delve into the intricacies of stability data in regulatory submissions and provide practical solutions to common challenges faced by pharmaceutical companies seeking marketing authorization.
Attendees will leave with a renewed sense of purpose and a deeper understanding of the impact their work. With practical insights and actionable strategies gained from the sessions, attendees will feel more confident in their ability to implement new ideas and improvements in their own stability study processes.
Register now for our Stability Studies conference
The third annual stability studies conference is taking place on Thursday 17th of October 2024 from 08:30 am to 15:30 pm at the Killashee Hotel, Naas.
Don’t miss this opportunity to advance your knowledge and career. Register now through our dedicated conference website or contact us to be part of the experience!
Q1 Scientific Conference – Stability Studies Conference 2024